The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic Origin

COVID-19 Clinical Trial

Official title:

Pilot Study: The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic Origin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04601077
• Other study ID #: IND150758 Pilot
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: November 1, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2022
• Source: Nitric Oxide Innovations LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a multi-center, randomized, double blinded, prospective, placebo controlled study. Patients upon diagnosis of COVID-19 (Corona Virus Disease-19) will be eligible to participate in the study. The purpose of this study is to find out the side effects and ability to take the study drug, Nitric Oxide (NO) lozenges when taken twice daily by mouth. If this study shows that the drug has no or few, acceptable side effects, it will then include up to 840 participants to find out if the drug can reduce bad outcomes of COVID-19 infection (hospitalization, ICU admission, death). In each part of the study, half of the subjects will receive the study drug and the other half will be given a placebo (inactive pill).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 524
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Male or female of 50-85 years of age

2. Subjects with recent COVID-19 diagnosis (within 72 hours), that are symptomatic (fever, cough, SOB, weakness, or other flu-like symptoms).

3. Agrees to comply with study procedures (diary, oximeter readings, telephone follow up).

4. Has given voluntary, written, informed consent to participate in the study.

5. Identifies as African American or Hispanic Origin

6. Patients must have at least 1 risk factor (history of hypertension (BP> 140/99) CHF, angina, prior MI, coronary angiography with one significantly occluded vessel, diabetes mellitus, obesity, or smoking, (for at least 5 years).

Exclusion Criteria:

1. Females who are pregnant, breastfeeding or planning to become pregnant during the course of the study.

2. Patients unresponsive or unable to take anything by mouth (NPO).

3. Individuals who are cognitively impaired and/or who are unable to give informed consent.

4. Blood pressure below 110 mmHg systolic and 60 mmHg diastolic on entry into study.

5. History of syncope or other symptoms of orthostatic hypotension.

6. History of methemoglobinemia.

7. Severe case of G6PD deficiency

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Nitric Oxide lozenges, 30 mg
Nitric Oxide lozenge, 30 mg twice a day for 30 days
• Placebo
Placebo for Nitric Oxide lozenge, 30 mg twice a day for 30 days

Locations

Country	Name	City	State
United States	American Institute of Therapeutics	Lake Bluff	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Nitric Oxide Innovations LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low blood pressure	Blood pressure under 90 mmHg	30 days
Primary	dizziness	Incidence of self reported dizziness	30 days
Secondary	Incidence of hospitalization, ICU admission, intubation, dialysis and death	The effects of NO therapy on incidence of hospitalization, intubation, ICU admission, dialysis and death in treated patients vs. those receiving placebo therapy.	30 Days